Basics of Clinical Trials What are Clinical trials

Basics of Clinical Trials

What are Clinical trials? Clinical trials are studies in which people volunteer to test new drugs or devices. Doctors use clinical trials to learn whether a new treatment works and is safe for people. These kinds of studies are needed to learn more about disease and develop new treatments. Clinical trials are a vital part of the scientific research process and are essential to developing better treatments for people.

What do clinical trials offer? Clinical trials are part of clinical research. Clinical trials help in medical advances by developing new ways to prevent, detect, or treat disease. Clinical trials can study-New drugs or new combinations of drugs -New ways of doing surgery -New medical devices -New ways to use existing treatments -New ways to change behaviors to improve health -New ways to improve the quality of life for people with acute or chronic illnesses. The goal of clinical trials is to determine if these treatment, prevention, and behavior approaches are safe and effective.

Who can participate in a clinical trial? People ( healthy volunteers and patients) of all ages can take part in clinical trials. If you find a clinical trial that interests you, there are steps and process must be followed to join the study (clinical trial). This involves some important initial steps like discussion with the doctor who conduct the clinical trial to understand about the clinical trial. You have to provide your consent for participation in the clinical trial after you get clarity on your role , responsibilities, risk and benefits to you. You may also discuss with your primary physician about your decision to participate in a clinical trial.

Why do people participate in a clinical trial? People take part in clinical trials for many reasons. Healthy volunteers take part to help others and to contribute to moving science forward. People with an illness or disease also take part to help others, but also to possibly receive the newest treatment and to have added care and attention from the clinical trial staff. Clinical trials offer hope for many people and a chance to help researchers find better treatments for others in the future

What are the types of clinical trials? There are two main types of clinical trialsobservational and interventional Observational clinical trials do not test drugs or treatments. Researchers observe participants by monitoring their health over a period of time. These studies provide researchers with data that advances our understanding of a disease and how to treat the disease Interventional clinical trials test the safety and effectiveness of a drug, device, therapy or experimental treatment.

What are the phases of clinical trials? Clinical trials are conducted in a series of steps called “phases. ” Each phase has a different purpose and helps researchers answer different questions. Phase I trials: Researchers test a drug or treatment in a small group of people (20– 80) for the first time. The purpose is to study the drug or treatment to learn about safety and identify side effects. Phase II trials: The new drug or treatment is given to a larger group of people (100– 300) to determine its effectiveness and to further study its safety. Phase III trials: The new drug or treatment is given to large groups of people (1, 000– 3, 000) to confirm its effectiveness, monitor side effects, compare it with standard or similar treatments, and collect information that will allow the new drug or treatment to be used safely. Phase IV trials: After a drug is approved by the FDA/regulatory body and made available to the public, researchers track its safety in the general population, seeking more information about a drug or treatment’s benefits, and optimal use.

What questions should I ask before I decide to participate in a clinical trial? The following are the important questions ( but not limited to) that one need to ask the doctor conducting a clinical trial? -What is the purpose of the study? -Why do researchers/doctors think the approach may be effective? -How are study results and safety of participants being monitored? -How long will the study last? -What will my responsibilities be if I take part? -Who will tell me about the results of the study and how will I be informed? -What are my possible benefits? -What are my risks, and side effects? -What other options are available? -How do the risks and possible benefits of this trial compare with those options? -What kinds of therapies, procedures and/or tests will I have during the trial? -Will I be able to take my regular medications while taking part in the clinical trial? -Where will I have my medical care and Who will be in charge of my care? -Will I have to pay for any part of the trial such as tests or the study drug? -What is my health insurance likely to cover? -Will there be any travel or child care costs that I need to consider while I am in the trial?

What is informed consent process in a clinical trial? Informed consent is the process of providing you with key information about a research study before you decide whether to accept the offer to take part. To help you decide whether to take part, members of the research team explain the details of the study. If you do not understand English, a translator or interpreter may be provided. The research team provides an informed consent document that includes details about the study, such as its purpose, how long it’s expected to last, tests or procedures that will be done as part of the research, and who to contact for further information. The informed consent document also explains risks and potential benefits. You can then decide whether to sign the document and take part in the study. Taking part in a clinical trial is voluntary and you can leave the study at any time.

What are clinical trials protocols? Clinical trials follow a plan known as a protocol. The protocol is carefully designed to balance the potential benefits and risks to participants, and answer specific research questions. A protocol describes the following: -The goal of the study -Who is eligible to take part in the trial -Protections against risks to participants -Details about tests, procedures, and treatments -How long the trial is expected to last -What information will be gathered A clinical trial is led by a principal investigator (PI)/doctor at the hospital/site. Members of the research team regularly monitor the participants’ health to determine the study’s safety and effectiveness.

What does the term Placebo mean in clinical trials? In clinical trials that compare a new product or therapy with another that already exists, researchers try to determine if the new one is as good, or better than, the existing one. In some studies, you may be assigned to receive a placebo (an inactive product that resembles the test product, but without its treatment value). Comparing a new product with a placebo can be the fastest and most reliable way to show the new product’s effectiveness. However, placebos are not used if you would be put at risk — particularly in the study of treatments for serious illnesses — by not having effective therapy. You will be told if placebos are used in the study before entering a trial.

What do the terms Randomization & Blinded mean in clinical trials? Randomization is the process by which treatments are assigned to participants by chance rather than by choice. This is done to avoid any bias in assigning volunteers to get one treatment or another. "Blinded" (or "masked") studies are designed to prevent members of the research team and study participants from influencing the results. Blinding allows the collection of scientifically accurate data. In single-blind ("singlemasked") studies, you are not told what is being given, but the research team knows. In a double-blind study, neither you nor the research team are told what you are given; only the pharmacist knows. Members of the research team are not told which participants are receiving which treatment, in order to reduce bias. If medically necessary (if there is serious adverse event), however, it is always possible to find out which treatment you are receiving.

How do clinical trials (clinical research) make difference to me and my family? -Clinical trials help in medical advances by developing new ways to prevent, detect, or treat disease -Clinical trials offer hope for many people and a chance to help researchers find better treatments for others in the future -Clinical trials help in finding out new ways to improve the quality of life for people with acute or chronic illnesses - Groundbreaking scientific advances in the present and the past were possible only because of participation of volunteers, both healthy and those with an illness, in clinical research - As research opens new doors to finding ways to diagnose, prevent, treat, or cure disease and disability, clinical trial participation help us find the answers

References v https: //www. nih. gov/health-information/nih-clinical-research-trialsyou/basics v https: //clinicaltrials. gov/ct 2/about-studies/learn v https: //www. cancer. org/treatments-and-sideeffects/clinical-trials/what-you-need-to-know/clinical-trialbasics. html v https: //clinicaltrials. gov/ct 2/home